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The Safety and PK Study of Inhaled ICF004 in Healthy Chinese Volunteers
Sponsor: Ruijin Hospital
Summary
The goal of this clinical trial is to learn about the safety of an inhaled study drug called ICF004 in healthy adults. ICF004 is being created to treat progressive lung scarring in the future. It will also learn how the body handles the drug over time. The main questions it aims to answer are: What medical problems or side effects do participants have when taking ICF004? How does the body absorb and metabolize ICF004? Researchers will compare ICF004 to a placebo (a look-alike powder that contains no active drug) to see if ICF004 is safe and well-tolerated. Participants will: Breathe in a single dose or multiple doses of ICF004 or a placebo using a dry powder inhaler; Stay at or visit the study clinic for checkups and tests; Give blood samples so researchers can measure the amount of drug in their blood.
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Inhaled Doses of ICF004 in Healthy Chinese Participants
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
73
Start Date
2026-07-30
Completion Date
2029-07-30
Last Updated
2026-07-22
Healthy Volunteers
Yes
Interventions
ICF004
Participants in the Single Ascending Dose (SAD) part will receive a single dose of ICF004 via dry powder inhaler. There are 5 planned dose cohorts (1, 4, 8, 12, and 16 mg).
Placebo
Participants in the Single Ascending Dose (SAD) part will receive a single dose of matching placebo via dry powder inhaler.
ICF004
Participants in the Multiple Ascending Dose (MAD) part will receive multiple doses of ICF004 via dry powder inhaler. The doses will be administered once daily (QD) or twice daily (BID). There are 4 planned cohorts. The exact dose levels will be determined based on the safety and tolerability results from Part 1.
Pacebo
Participants in the Multiple Ascending Dose (MAD) part will receive multiple doses of matching placebo via dry powder inhaler, administered once daily (QD) or twice daily (BID).